N/A 2ACHCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000280024), received between Mar 31, 2021 and Sep 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724748 ↗
• MalfunctionOct 31, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A CARDIAC ABLATION PROCEDURE, DURING PREPARATION THE CABLE 2ACHC ACHIEVE ST 10-PIN WAS CONSIDERED UNSTERILE DUE TO BEING FOUND UNSEALED. THE CABLE 2ACHC ACHIEVE ST 10-PIN WAS REPLACED WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441833 ↗
• MalfunctionJun 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHILE SETTING UP MATERIALS FOR A PROCEDURE, THE INNER PACKAGING OF THE ACHIEVE CABLE WAS FOUND TO BE ALREADY OPENED. THIS ISSUE WAS IDENTIFIED WITH FOUR CABLES. THE CABLES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149024 ↗
• MalfunctionJun 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHILE SETTING UP MATERIALS FOR A PROCEDURE, THE INNER PACKAGING OF THE ACHIEVE CABLE WAS FOUND TO BE ALREADY OPENED. THIS ISSUE WAS IDENTIFIED WITH FOUR CABLES. THE CABLES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149017 ↗
• MalfunctionJun 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHILE SETTING UP MATERIALS FOR A PROCEDURE, THE INNER PACKAGING OF THE ACHIEVE CABLE WAS FOUND TO BE ALREADY OPENED. THIS ISSUE WAS IDENTIFIED WITH FOUR CABLES. THE CABLES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149011 ↗
• MalfunctionJun 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHILE SETTING UP MATERIALS FOR A PROCEDURE, THE INNER PACKAGING OF THE ACHIEVE CABLE WAS FOUND TO BE ALREADY OPENED. THIS ISSUE WAS IDENTIFIED WITH FOUR CABLES. THE CABLES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149006 ↗
• MalfunctionMay 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE STERILE PACKET CONTAINING THE MAPPING CATHETER CABLE WAS NOT SEALED, COMPROMISING STERILITY. THE MAPPING CATHETER CABLE WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003052 ↗
• MalfunctionMar 31, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNDEFINED PARTICLE WAS OBSERVED IN THE PACKAGING OF THE MAPPING CATHETER CABLE WHEN REMOVING IT. THE MAPPING CATHETER CABLE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595067 ↗